COMPANY BACKGROUND
Since 1996, the services of  The AquaMarine Group, Inc. have been sought and retained by pharmaceutical firms to furnish expertise in the areas of regulatory review, application writing, cGMP compliance/mock pre-approval audit, R&D portfolio analysis, contracted management services, and new product/technology evaluation and promotion.

REGULATORY AND QUALITY SERVICES
Filing services include review/writing of Chemistry and Manufacturing Controls (CMC) sections for NDAs, ANDAs, INDs (biologicals and new chemical entities), DMFs, 510(k)s, NDSs, ANDSs, MAAs/CTXs and International filings. Other services include due diligence, cGMP audit, Quality Operations (QC/QA), mock pre-approval inspections, R&D portfolio, and Business Analysis, Manufacturing scale-up, Medical devices, Formulation, cGMP Training, SAS, Bioequivalence.